CLASS II Device recall · Reported 5 Oct 2016 · FDA Enforcement Report
DRI Salicylate Serum Tox Assay recalled by Microgenics
Microgenics is recalling DRI Salicylate Serum Tox Assay, distributed nationwide in the US. The recall was initiated on 25 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2884-2016
- FDA event ID
- 74861
- Recalling firm
- Microgenics, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2016
- FDA classified
- 23 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jul 2016 | Recall initiated by company | |
| 23 Sep 2016 | Classified by FDA | +60 days |
| 5 Oct 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
Questions about this recall
Why was it recalled?
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Which lots are affected?
Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.
Where was it sold?
Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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